# FDA 483 - FUJIFILM Healthcare Americas Corporation - April 09, 2015

Source: https://www.keypedia.com/records/483/fujifilm-healthcare-americas-corporation/5cc6c822-733a-4cfe-ab84-4f17fa678e9b

> FDA 483 for FUJIFILM Healthcare Americas Corporation on April 09, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM Healthcare Americas Corporation
- Inspection Date: 2015-04-09
- Product Type: Devices
- Office Name: New Jersey District Office
- Summary: The FDA Form 483 details multiple violations concerning complaint handling, investigations, corrective actions, and reporting for duodenoscopes.

**Complaint Handling Deficiencies:**
*   Complaints involving device/labeling failure were not consistently reviewed, evaluated, and investigated.
*   Procedure QA-002, "Reporting Customer Complaints," does not require a complaint record for all alleged deficiencies, specifically excluding device failures due to damage.
*   Procedures for receiving, reviewing, and evaluating complaints for Medical Device Reporting (MDR) were inadequate, with a lack of MDR reportability review for work orders related to malfunctioned duodenoscopes.

**Investigation Lapses:**
*   Lack of investigations into failed, returned, and repaired duodenoscopes, including specific instances of fluid damage, light guide assembly damage, and leaks (e.g., ED-530XT Serial No. 4D102A084, 5D102A510; ED-450XTS Serial No. 1D080A030).
*   Absence of root-cause investigations for recurring issues such as Distal End Cap failures, image failures with water leaks, and peeled surface components on ED-530XT duodenoscopes.

**Corrective and Preventive Actions (CAPA) Inadequacies:**
*   Procedure QA-006, "Corrective Actions / Preventive Actions (

## Related Documents

- [WARNING_LETTER - 2015-05-01](https://www.keypedia.com/records/warning_letter/fujifilm-healthcare-americas-corporation/e024b9ff-36ce-43ac-a32d-ca1daf1e1104)
- [483 - 2019-07-02](https://www.keypedia.com/records/483/fujifilm-healthcare-americas-corporation/66a3154e-a133-43af-b37d-f36733e1a0e8)

## Related Officers

- [Xin Li](https://www.keypedia.com/people/xin-li/8021b79a-7689-4826-8bf9-52d92a16060c)

Company: https://www.keypedia.com/companies/fujifilm-healthcare-americas-corporation/2e493068-8e15-45e6-b777-5a484d761611

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248